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20-09-2017 | FDA | News

approvalsWatch

Copanlisib, low-dose cabazitaxel receive FDA go ahead

medwireNews: The US FDA has granted accelerated approval for the use of copanlisib for patients with relapsed follicular B-cell non-Hodgkin lymphoma and agreed that men with metastatic castration-resistant prostate cancer may be given a lower dose of cabazitaxel than previously recommended.

Copanlisib, a class I phosphoinositide 3-kinase inhibitor, may now be used by adults who have previously received at least two prior systemic treatments for follicular lymphoma, including rituximab and an alkylating agent.

The approval follows positive phase II trial findings for the agent at a dose of 60 mg administered over a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day cycle. Common grade 3–4 adverse events listed include hyperglycemia, leukopenia, hypertension, and neutropenia.

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Low-dose cabazitaxel, a semi-synthetic taxoid derivative, has been approved for use alongside prednisone for patients who have previously received docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer.

The decision follows noninferiority overall survival data from the PROSELICA trial for cabazitaxel 20 mg/m2 versus the standard 25 mg/m2 dose, at a median of 13.4 and 14.5 months, respectively.

The lower dose regimen was associated with a reduced rate of adverse events, such as myelosuppression, infections, and toxicity, as well as lower rates of infection-related deaths within 30 days of beginning treatment and deaths within 30 days of last study dose.

The recommended cabazitaxel regimen is now 20 mg/m2 every 3 weeks given as a 1-hour intravenous infusion plus oral prednisone 10 mg/day, with the higher cabazitaxel dose allowed in select patients at the physician’s discretion.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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